Since the respiratory units have had to admit patients with covid sequelae or readmit former patients

SIMAP is a triple-masked randomised trial aimed at assessing whether an automated system of pictograms associated to medical indications results in better comprehension and adherence of said indications. Adult patients with a recent diagnosis of asthma will be randomised to receive a pictographic depiction of their treatments and recommended interventions or standard communication without assistance from their attending physician. Patients will be followed-up for 60 days using the Asthma Control Questionnaire (ACT). The primary endpoint of this study is the degree of asthma control as assessed by the aforementioned questionnaire. Secondary outcomes include the number of hospitalisations, emergency care unit visits and the need to increase bronchodilator therapy as per current Global Initiative for Asthma guidelines. Outcomes will be analysed under the intention-to-treat principle by a statistician unaware of treatment allocation.

In this triple-masked randomised trial, adult participants with a recent diagnosis of asthma (<15 days) will be allocated to receive a pictographic depiction of their medical indications or a standard description of said indications. Eligible patients will include those between 18 and 65 years of age with a diagnosis of asthma established by standard clinical recommendations (clinical and spirometric criteria as established by Global Initiative for Asthma - GINA - guidelines) and in whom therapy including a bronchodilator and a controller medication (typically an inhaled steroid) is planned to be initiated. Patients with another cause of bronchial obstruction (such as COPD), those with cognitive or visual impairments that hampers the understanding of pictograms or those with a history of alcoholism or alcohol abuse will be excluded. Patients will be randomised using a permuted block sequence which shall be kept hidden from other investigators. Participants will be followed-up at seven, thirty and sixty-day intervals using the Asthma Control Questionnaire (ACT), which is the primary outcome of this study. Participants, clinical evaluators, analysts and sponsors will be kept unaware of treatment allocation. Secondary endpoints include the inhaler technique, the correct depiction of inhaler medication purpose, the rate of emergency care visits between groups, the rate of hospitalisations between groups and the need to increase bronchodilator therapy during scheduled visits within the trial. All analyses will be conducted using the intention-to-treat principle.

Inclusion Criteria:

• Adult patients aged 18 to 65 years with a recent diagnosis of bronchial asthma (<=15 days) based on 2018 Global Initiative For Asthma (GINA) criteria.
• Diagnosis substantiated clinically and with consistent spirometry results as established by current GINA guidelines.
• Patients who are to initiate bronchodilator treatment, including at least one inhaled corticosteroid and one short-acting bronchodilator.

Exclusion Criteria:

• Patients presenting obstructive bronchial pathology other than bronchial asthma (chronic obstructive pulmonary disease, mixed states, etc.),
• Patients who have participated in the pictogram design phase (Stage 1 of the project),
• Patients with a diagnosis of dementia, diagnosis of harmful use of alcohol and other drugs according to the International Classification of Diseases (ICD-10).
• Patients with significant ophthalmologic pathology that prevents the use of pictograms.
• Patients who do not wish to participate in the project.

The pictogram group initially consisted of 10 patients who signed the informed consent. However, after signing, one of the patients withdrew from the study and did not answer to the instruments. Despite being initially assigned to the pictogram group, we lack details about the baseline characteristics of this patient. As a result, this individual was not included in the total count of patients in the pictogram group for the baseline analysis.

Adverse events were collected from the day the intervention was applied until the end of the follow-up period (60 days). Patients were provided with the principal investigator's phone number to report any adverse events that occurred after the 60-day period. No adverse events were reported.

No adverse events were reported.

Unfortunately, the progression of the COVID-19 health crisis led to the suspension of this study. In response to the unprecedented circumstances, the study protocol underwent necessary amendments related to COVID-19 before resuming. The revised protocol with amendments received approval.

Due to the shift in priorities caused by the COVID-19 crisis, the flow of patients diagnosed with bronchial asthma was lower than anticipated in the study.

Participants, clinical investigators, outcome assessors, analysts and sponsors will be kept unaware of treatment allocation. The masking of the participating patients will be carried out through an informative brochure on bronchial asthma delivered as part of the usual education, albeit without using pictograms.